Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

There are currently no treatments to specifically target asthma in obese adults. This pilot study is being conducted to investigate how effective roflumilast is in treating asthma in participants that have a higher BMI. Roflumilast can induce weight loss, which may lead to improved asthma control. The primary objective of TRIM is to perform a pilot placebo-controlled trial of roflumilast for the treatment of poorly controlled obese asthmatics.

Details

TRIM is a 24 week, randomized, double-masked, placebo controlled trial that will enroll 38 participants.

This study will be take place in six centers of the American Lung Association- Airways Clinical Research Centers (ALA-ACRC). The centers include: Northwestern University Feinberg School of Medicine, Mount Sinai Icahn School of Medicine, Duke University, University of Arizona, University of Vermont, and the University of California at San Diego. Johns Hopkins University will be the Data Coordinating Center (DCC) for the trial.

Keywords

Asthma Obesity Roflumilast 500 Mcg Oral Tablet

Eligibility

You can join if…

Open to people ages 18 years and up

  • Physician diagnosis of asthma on regular prescribed controller therapy for at least 3 months
  • Current or previous (within two years) evidence of a positive methacholine challenge

Age: ≥18 years of age

  • Obese: BMI > 30 kg/m2
  • Poorly controlled asthma: Asthma Control Test Score < 20, or use of rescue inhaler, on an average of> 2 uses/week for preceding month, or nocturnal asthma awakening, on an average of 1 or more times / week in preceding month, or emergency department(ED)/hospital visit or prednisone course for asthma in past six months.
  • Ability and willingness to provide informed consent

You CAN'T join if...

  • Participation in an investigational study within the past 4 weeks
  • Physician diagnosis of chronic obstructive pulmonary disease
  • Any condition that puts the participant at risk from weight loss as judged by the site physician
  • Liver cirrhosis
  • Major psychiatric disorders such as major depressive disorder, history of suicidal ideation/ attempt, panic disorder, post-traumatic stress disorder, schizophrenia,schizoaffective, substance abuse or other disorders that in the opinion of the study physician that would affect study participation
  • =/> 1 time use of illicit drugs in the past 12 months
  • =/> 1 time use of cannabis in the past 12 months
  • Uncontrolled depression as defined by a score of 10 or greater on the depression questions of the PHQ-9
  • Suicidal ideation (a score of greater than 0 on Question 9 on the PHQ-9)
  • Uncontrolled anxiety as defined by a score of 10 or greater on the anxiety questions of the Generalized Anxiety Disorder 7-item (GAD-7)
  • Pregnancy/lactation
  • Females of childbearing age who do not agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study.
  • Greater than 20 pack year smoking history, or smoking within the last 6 months.
  • History of bariatric surgery
  • Drugs metabolized by cytochrome P450 (rifampicin, phenobarbital, carbamazepine,phenytoin, erythromycin, ketoconazole, cimetidine, fluvoxamine, enoxacin, oral contraceptives containing ethinyl estradiol with gestodene ).
  • Currently on roflumilast or theophylline (patient may wash out of these medications for 4 weeks prior to visit 1)
  • Intention to move out of area within the next 6 months

Locations

  • University of California at San Diego in progress, not accepting new patients
    San Diego California 92103 United States
  • University of Arizona in progress, not accepting new patients
    Tucson Arizona 85724 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Johns Hopkins University
ID
NCT03532490
Phase
Phase 2
Study Type
Interventional
Last Updated
August 29, 2018